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Cepheid FDA Approvals

0 new drug approvals and 23 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Xpert Respiratory Panel510(k)Sep 25, 2026Microbiology
Xpert Hemorrhagic Fever510(k)Aug 7, 2026Immunology
Xpert Carba-R510(k)Jul 2, 2026Microbiology
Xpert Hemorrhagic Fever510(k)Feb 20, 2026
Xpert GI Panel510(k)Jan 16, 2026Microbiology
Xpert Xpress CoV-2/Flu/RSV plus510(k)May 1, 2025Microbiology
Xpert Xpress CoV-2/Flu/RSV plus510(k)May 1, 2025Microbiology
Xpert C. difficile/Epi510(k)Feb 28, 2025Microbiology
Xpert® FII & FV510(k)Feb 21, 2025Hematology
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)510(k)Jan 15, 2025Microbiology
Xpert Xpress CoV-2/Flu/RSV plus510(k)Jan 10, 2025Microbiology
Xpert MRSA/SA SSTI510(k)Dec 18, 2024Microbiology
Xpert vanA510(k)Nov 21, 2024Microbiology
Xpert® SA Nasal Complete510(k)Oct 25, 2024Microbiology
Xpert HCV; GeneXpert Xpress System510(k)Jun 27, 2024Microbiology
Xpert Xpress MVP; GeneXpert Xpress System510(k)Oct 19, 2023Microbiology
Xpert® Xpress CoV-2 plus510(k)Oct 13, 2023Microbiology
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems510(k)Sep 27, 2023Microbiology
Xpert Xpress CoV-2/Flu/RSV plus510(k)Aug 17, 2023Microbiology
Xpert® FII & FV510(k)Feb 15, 2023Hematology
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System510(k)Jun 7, 2022Microbiology
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System510(k)May 9, 2022Microbiology
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System510(k)Feb 9, 2022Microbiology

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